Stepped Wedge Trial of an Intervention to Support Proxy Decision Makers in ICUs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pittsburgh
- Enrollment
- 848
- Locations
- 2
- Primary Endpoint
- Quality of Communication (QOC) scale
Study Overview
Brief Summary
This is a stepped wedged randomized controlled trial comparing the PARTNER intervention with usual care in 5 Intensive Care Units. The overarching goal of this research project to ensure patient-centered decisions about the use of intensive treatments for patients with advanced critical illness. In a prior project, the investigators developed the PARTNER program (PAiring Re-engineered ICU Teams with Nurse-driven Education and OutReach), a 4-facet, team-based intervention that re-engineers how surrogates are supported in ICUs, including: 1) changing care "defaults" to ensure clinician-family meetings within 48 hours of enrollment and frequently thereafter; 2) protocolized, nurse-administered coaching and emotional support of surrogates before and during clinician-family meetings, 3) increased use of palliative care services for patients with a poor prognosis. The investigators propose to begin deployment of the PARTNER II program in the spring of 2015 enrolling 690 surrogate decision makers in 5 ICUs using a stepped wedge design. The investigators expect to achieve the following project goals:
- To increase the patient-centeredness of end-of-life decisions, and to increase the quality of clinician-family communication.
- To decrease the psychological burden on family members acting as surrogates.
- To reduce total health care costs by decreasing the duration of use of burdensome, invasive treatments at the end of life.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •18 years of age or older
- •Surrogate decision maker for ICU patient in one of 5 UPMC ICU's
Exclusion Criteria
- •Non-English Speaking
- •Surrogate's loved one is for organ transplantation
- •Not physically able to participate in family meeting
Arms & Interventions
Control
The control group will receive usual care, in which the frequency and content of physician-family communication is determined by the clinical team according to their usual practice. No study ICU has a protocolized approach to family communication and instead clinicians determine the timing and frequency of communication with families. All sites have palliative care services.
Behavioral: The PARTNER II Intervention
The PARTNER intervention is a multifaceted intervention delivered by a trained "PARTNER Champion" who has undergone 16 hours of intense communication training, with audit and feedback, quarterly booster training, and expert implementation support. Additionally, there is academic detailing of ICU physicians and ICU bedside nurses to augment the intervention. The PARTNER Intervention deploys three strategies to improve: 1) the timeliness and frequency of clinician-family communication, 2) the emotional and decision support provided to families and 3) the appropriate involvement of palliative care specialists.
Intervention: PARTNER II (Behavioral)
Outcomes
Primary Outcomes
Quality of Communication (QOC) scale
Time Frame: At 6 months
We will assess quality of communication in family members in a telephone interview 6 months after enrollment using the validated13 item Quality of Communication Scale.
Secondary Outcomes
- Intensive Care Unit Length of Stay(Participants will be followed for duration of ICU stay, an expected average of 21 days)
- Hospital Anxiety and Depression Scale(At 6 months)
- Patient-Centeredness of Care Scale(At 6 months)
- Impact of Events Scale(At 6 months)
- Decision Regret Scale(At 6 months)
Investigators
Douglas White
Vice Chair and Professor of Critical Care Medicine
University of Pittsburgh